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Claims for Patent: 4,439,423

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Claims for Patent: 4,439,423

Title: Chymopapain and method for its use
Abstract:An improved method for treating an intervertebral spinal disc in a mammalian subject which disc exhibits an abnormal condition, characterized by a reduced risk of toxic effect to the subject is provided which comprises, injecting in said disc an amount of a pharmaceutically acceptable solution of a purified chymopapain essentially free of proteolytically inactive and/or toxic protein components, said purified chymopapain being used in an amount sufficient to selectively dissolve the nucleus pulposus of said disc. Pharmaceutical compositions are also provided for said method which include a purified proteolytically active lyophilized chymopapain, essentially free of proteolytically inactive and toxic components, and an activating amount of a pharmaceutically acceptable reducing agent.
Inventor(s): Smith; William S. (Libertyville, IL)
Assignee: Smith Laboratories, Inc. (Rosemont, IL)
Application Number:06/263,197
Patent Claims: 1. A pharmaceutical composition consisting of an effective amount of a purified chymopapain product essentially free of proteolytically inactive component materials and characterized by the absence of precipitate formation when a 10% weight/volume solution of said purified chymopapain is acidified with hydrochloric acid followed by treatment with barium chloride; and a minor amount of a pharmaceutically acceptable, non-toxic, reducing agent said composition being further characterized as being free of bisulfite additives.

2. A pharmaceutical composition according to claim 1 wherein the reducing agent is sodium cysteinate hydrochloride.

3. A purified pharmaceutical composition of claim 1 further characterized by being free of ethylene diaminetetraacetic acid.

4. A stable pharmaceutical composition comprising an effective amount of a lyophilized purified chymopapain characterized by being essentially free of proteolytically inactive component materials and bisulfite and relatively non-toxic, and further characterized by the absence of precipitate formation when a 10% weight/volume solution is acidified with hydrochloric acid followed by treatment with barium chloride; and a minor activating amount of a pharmacologically acceptable reducing agent; said reducing agent being present in said composition in an amount of from about 10 to about 20 percent by weight of the purified chymopapain.

5. A pharmaceutical composition according to claim 4 wherein the reducing agent is sodium cysteinate hydrochloride.

6. A composition according to claim 5 wherein the sodium cysteine is present in the amount of at least about 15% by weight of the purified chymopapain solids.

7. A composition according to claim 4 containing about 23 mg of said purified chymopapain.

8. A composition according to claim 7 containing about 3 to 3.6 mg of sodium cysteinate hydrochloride.

9. A stable pharmaceutical composition in dosage unit form for use in dissolving the nucleus pulposus of an intervertebral disc by injection which comprises about 10,000 to about 11,500 proteolytic units of a purified essentially colorless chymopapain, said purified chymopapain being characterized by its being essentially free of protein components which are proteolytically inactive and being free of bisulfite and further characterized by the absence of precipitate when an acidified aqueous solution of said chymopapain is treated with barium chloride reagent and a sodium cysteinate hydrochloride activating agent, said composition being packaged in a vacuum container.

10. A pharmaceutical composition in dosage unit form according to claim 9 wherein the purified chymopapain is present in an amount of 23 milligrams and the sodium cysteinate hydrochloride is present in an amount of about 3.5 milligrams.

11. A method of treating an intervertebral spinal disc in a mammalian subject which disc exhibits an abnormal condition, characterized by a reduced risk of toxic effect to the subject which method comprises the step of injecting into said disc an effective amount of a pharmaceutically acceptable aqueous solution of a purified chymopapain which is essentially free of proteolytically inactive and toxic protein components and bisulfite and is characterized by its failure to form a precipitate in an acidified aqueous solution when treated with a solution of barium chloride, and which solution contains a minor amount of sodium cysteinate hydrochloride solution sufficient to activate the chymopapain, said purified chymopapain being used in amounts sufficient to selectively dissolve the nucleus pulposus of said disc.

12. A method according to claim 11 wherein the abnormal disc is a herniated intervertebral disc.

13. A method according to claim 11 wherein the purified chymopapain is an admixture of chymopapain I and II.

14. A method of treating a herniated intervertebral spinal disc in an mammlian subject which comprises the steps of:

(a) inserting the needle into said disc;

(b) confirming the placement of said needle by means of x-ray; and

(c) injecting into said disc an effective amount of a pharmaceutically acceptable aqueous solution of a relatively non-toxic, purified chymopapain characterized as essentially free of proteolytically inactive components and bisulfite, and by its failure to form a precipitate when an acidified solution thereof is treated with barium chloride reagent, and a pharmaceutically acceptable non-toxic reducing and activating agent for said purified chymopapain; to selectively dissolve said disc.

15. A method according to claim 14 wherein the activating agent is sodium cysteinate hydrochloride.

16. A method according to claim 15 wherein the sodium cysteinate hydrochloride activating agent is present in an amount of at least 10% by weight of the chymopapain on a dry solids basis.

17. A method according to claim 14 wherein the purified chymopapain is an admixture of chymopapain fractions I and II.
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